We are looking for a specialist to control and approval of politices, procedures, acceptation criteria’s, qualification and document validation (plan, protocol, reports), indications of deviations for all computer systems related to:
Labo systems (camera’s, kartoneerders, MES, autoclaven, serialisatiesystemen ...),
Labo systemen (HPLC, GC, Empower, Lims , FTIR, NIR ...)
IT systemen (SAP, routers, servers, firewalls …)
What you’ll do
- Assurance of the harmonized computer systems in projects where computer systems are involved.
- Aligning with authors the comments with the review.
- Give quality CSV input of deviation researches within validation (review of final reports, shut down of tasks in SAP)
- Support to inspection and audits activities related to computer system questions
- Promotion of GMP awareness and culture
- Documents are written in Dutch and English
- Strong affinity with IT as well as GMP standards.
- Experience with Quality assurance and work review of GMP standards in the pharmaceutical industry.
- Scientific background or knowledge acquired from experience in QA of cGMP environments
- Analytical, organized, eye for detail, knowledge of MS Office
- English and Dutch are a must
- Knowledge of the following standards is a plus: GAMP5; ICH Q9/Q10; FDA/EU/WHO regulations on CSV (21CFR210/211/820/Part11; EU Vol4 annex11.